Cleared Traditional

K924200 - REFLEX ESC

K924200 is the FDA 510(k) clearance for REFLEX ESC by Richard-Allan Medical Ind., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code KNF) cleared through the Traditional 510(k) pathway after a 551-day FDA review.

K924200 · Richard-Allan Medical Ind., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
551d
Days
Class 2
Risk

K924200 is an FDA 510(k) clearance for the REFLEX(R) ESC. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 551 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Richard-Allan Medical Ind., Inc. devices

Submission Details

510(k) Number K924200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date February 22, 1994
Days to Decision 551 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
391d slower than avg
Panel avg: 160d · This submission: 551d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 19
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K924200.
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ENDOMED LAPAROSCOPY INSTRUMENTS
K921686 · Buckman Co., Inc. · Mar 1994
ELECTRO-GYNE ELECTROSURGICAL GENERATOR
K871960 · Cabot Medical Corp. · Jul 1987